FDA Panel Votes in Favor of Inhalable Insulin; Diet Drug Recalled

FDA Panel Votes in Favor of Inhalable Insulin
On April 1, a US Food and Drug Administration (FDA) advisory panel voted in favor of Afrezza, an inhalable insulin/inhaler combination, for the treatment of Type 1 and Type 2 diabetes in adults.

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Afrezza is comprised of a premeal insulin powder and a whistle-size device that the powder is loaded into for inhalation. MannKind Corporation, the developer, is seeking approval for the product as an ultrarapid-acting insulin treatment for adults with Type 1 or Type 2. In those with Type 1, the insulin would be for use along with injected basal (background) insulin.

The Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 in favor of Afrezza for Type 1 diabetes and 14-0 for Type 2 diabetes. Members noted the benefits of the insulin’s rapid onset of action and short duration, which lowers the risk for low blood glucose, and also cited the potential advantages of inhalable insulin for people with Type 2 who may not wish to or be able to give themselves injections.

The panel members did, however, express concerns about data indicating the inhalable medicine is less effective at lowering blood glucose in people with Type 1 compared to short-acting injectable insulin. They also noted the lack of long-term information on the drug’s effects on lung function and lung cancer risk. The panel made recommendations to the FDA for labeling requirements and postmarketing studies to address these concerns.

“My greatest concern is related to the cancer risk, and I think the way I saw the data, the efficacy of this was not as good as [injectable] insulin,” noted panel member David Cooke, MD. But “the convenience and desirability of avoiding injections and ease of use and all the hurdles that injections impose upon diabetics” are an “unambiguous benefit,” he added.

Exubera, an inhalable insulin approved in the United States in 2006, was discontinued by manufacturer Pfizer in 2007. The drug’s high price and bulky inhaler, along with concerns about lung function, led to much lower sales than expected.

The FDA is not required to follow the advice of its advisory panels, but it typically does. The agency is expected to make a final decision on Afrezza by April 15. (Editor’s note: As of April 7, the FDA has pushed its review date back by three months. The agency is now expected to make a decision on July 15.)

For more information, read the articles “FDA Panel Says Yes to Inhaled Insulin Device” and “FDA Advisory Panel Endorses Inhaled-Insulin Product Afrezza.”

Diet Drug Recalled
On March 27, pharmaceutical manufacturer GlaxoSmithKline (GSK) Consumer Healthcare voluntarily recalled all nonprescription supplies of the weight-loss drug alli (generic name orlistat) from retailers in the United States and Puerto Rico due to tampering concerns.

Alli capsules are a turquoise-blue with a dark blue band that has the text “60 Orlistat.” GSK said consumers have reported buying bottles of alli containing a “range of tablets and capsules of various shapes and colors.” Some of the bottles were also missing labels and had inauthentic tamper-evident seals. Authentic bottles of the medicine are labeled and have an inner foil seal with the words “Sealed for your Protection.”

“We have received reports of about 20 bottles purchased by 12 consumers in seven states: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas,” noted senior external communications manager Deborah Bolding.

Bottles with the following lot numbers and expiration dates have been reported to contain a product other than alli: 14372, February 28, 2016; 14395, February 28, 2016; 14124, September 30, 2015; 14267, January 31, 2016; 14442, April 30, 2016.

Consumers are advised not to use alli they have purchased if they are unsure or concerned about whether it is authentic. They are asked to call GSK at (800) 671-2554 to speak with a representative. People who have consumed any questionable product should contact their health-care provider.

For more information, see myalli.com.

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